ro 50-3821 in treating anemia in patients receiving antineoplastic therapy for stage iiib or stage iv non-small cell lung cancer

Conditions: Anemia; Lung Cancer

Summary: rationale: ro 50-3821 may stimulate red blood cell production and treat anemia in patients who are receiving antineoplastic therapy for non-small cell lung cancer. purpose: this randomized phase ii trial is studying six different regimens of ro 50-3821 to compare how well they work in treating anemia in patients who are receiving antineoplastic therapy for stage iiib or stage iv non-small cell lung cancer.

objectives: primary * compare the hemoglobin dose response of anemic patients with stage iiib or iv non-small cell lung cancer receiving antineoplastic therapy treated with 6 different regimens of ro 50-3821. secondary * compare the safety profile of these regimens in these patients. * compare the pharmacokinetic profile of these regimens in these patients. * determine additional pharmacodynamic characteristics of these regimens in these patients. outline: this is a randomized, open-label, parallel, multicenter study. patients are randomized to 1 of 6 treatment arms. in all arms, patients begin study therapy on the first day of a course of antineoplastic therapy. * arm i: patients receive a lower dose of ro 50-3821 subcutaneously (sc) once weekly. * arm ii: patients receive a medium dose of ro 50-3821 sc once weekly. * arm iii: patients receive a higher dose of ro 50-3821 sc once weekly. * arm iv: patients receive a lower dose of ro 50-3821 sc once every 3 weeks. * arm v: patients receive a medium dose of ro 50-3821 sc once every 3 weeks. * arm vi: patients receive a higher dose of ro 50-3821 sc once every 3 weeks. in all arms, treatment continues for 12 weeks in the absence of unacceptable toxicity. patients are followed at 1 week. projected accrual: a total of 210 patients (35 per treatment arm) will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed non-small cell lung cancer * stage iiib or iv * currently receiving first- or second-line antineoplastic therapy (must be scheduled to receive therapy during the 12 weeks of study therapy) * antineoplastic therapy may include single agent or combination chemotherapy, corticosteroids, or a combination of these agents * hemoglobin no greater than 11 g/dl * transfusion independent * no known primary or metastatic cns malignancy patient characteristics: age * 18 and over performance status * ecog 0-2 life expectancy * more than 6 months hematopoietic * see disease characteristics * platelet count 50,000-500,000/mm\^3 * no functional iron deficiency\* (e.g., transferrin saturation less than 20% or serum ferritin less than 100 ng/ml) * no known hemolysis note: \*concurrent iron supplementation to correct deficiency allowed hepatic * not specified renal * creatinine no greater than 2.5 mg/dl cardiovascular * no clinically significant hypertension other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no other malignancy within the past 5 years except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix * no acute or chronic bleeding requiring therapy within the past 3 months (e.g., patients with anemia caused by gastrointestinal bleeding) * no known cyanocobalamin deficiency * no known folic acid deficiency * no acute infection or inflammatory disease (c-reactive protein greater than 50 mg/l) * no known resistance to epoetin administration * no newly diagnosed (i.e., within the past 6 months) or uncontrolled epilepsy prior concurrent therapy: biologic therapy * more than 8 weeks since prior recombinant human erythropoietin therapy or any other erythropoiesis-stimulating drugs chemotherapy * see disease characteristics endocrine therapy * see disease characteristics radiotherapy * more than 4 weeks since prior radiotherapy surgery * not specified other * more than 4 weeks since prior red blood cell transfusion * more than 30 days since prior investigational drugs or regimens * no prior enrollment and randomization to this study * no other concurrent investigational drugs or regimens

Keywords: anemia stage iiib non-small cell lung cancer stage iv non-small cell lung cancer recurrent non-small cell lung cancer